Effect of Local Use of Vitamin D on the Rate of Canine Distillization: a Split Mouth Randomized Control Trial

NCT07479290 | Recruiting Phase 1

• 1 other identifier: FUCD-Ortho-2502
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Orthodontic treatment (OT) is characterized as a lengthy procedure and enormous effort has been harnessed to shorten the OT duration using either surgical or non-surgical approaches. With the emerging concept of "accelerated orthodontics," scientific interest has been focused on chemical and electrical stimuli in combination with mechanical forces for rapid bone turnover and more stable results. Given the role of cytokines, parathyroid hormone, active vitamin D3 (1,25 dihydroxycholecalciferol) in bone regeneration, several studies have been conducted in which exogenous biological molecules have been locally administrated in order to stimulate orthodontic tooth movement. Vitamin D (Vit-D) plays a significant role in bone biology and remodeling.There are two primary forms of Vit-D: 25-OHD (25-hydroxyvitamin D) and 1,25 DHC (1,25-dihydroxycholecalciferol) which is the active form. 1,25 DHC is a potent stimulator of osteoclastic activity by inducing differentiation as well as increasing the activity of osteoclasts. It is also known to work in a dose-dependent way. Although it has a 2-3-hour plasma half-life, its effects on cells might last for days. Injecting the active form of Vitamin D can increase tooth movement, decrease the treatment time of fixed appliances and maintain the integrity of the bone. In the past researches have been done on cats and rodents on the effect of intraligamentary administration of vitamin D3 on tooth movement. Studies performed on human beings are few and inconclusive. Two out of the four studies done on humans were cross-sectional and investigated the role of active vitamin D on external apical root resorption. The other two clinical trials used split-mouth technique and examined the impact of local CTL administration on tooth movement rate, both demonstrating level 1 of evidence and high recommendation. Al-Hasani and colleagues reported that a low dose of 25 picogram/mL produced a higher rate of OTM, with no statistically significant difference between the study and control sides in 15 patients involved in the study. However, Iosub Ciur and colleagues reported 70% acceleration in the OTM when using higher 42 picogram/mL local dose of vit D, but the number of patients was extremely low and not adequate(n=4) in this study. The purpose of our study is to evaluate if higher doses of local vitamin D can accelerate tooth movement in adequate number of adult patients. If vitamin D in our population of adult patients can accelerate tooth movement, then it can allow for more predictable treatment outcome during fixed orthodontic therapy.

Conditions

Malocclusion of Anterior Teeth

Keywords

Vitamin D; Malocclusion; accelerated Orthodontics; 1,25 dihydroxycholecalciferol; canine distillization

Outcome Measures

Primary Outcomes (1)

• complete canine distillization

  patients will be given 1,25 DHC injection at 3 time points and complete canine movement will be measured on study casts

  1 years

Study Arms (2)

Control Group: placebo

PLACEBO COMPARATOR

Participants in this arm will receive only placebo DMSO solution

Drug: Placebo: plain DMSO solvent

Experimental group: 1,25 DHC in DMSO

EXPERIMENTAL

Experimental group will receive active vit D injection mixed with DMSO liquid

Dietary Supplement: Experimental: 1,25 DHC injection

Interventions

Experimental: 1,25 DHC injection DIETARY_SUPPLEMENT

Experimental: participants will receive 1,25 DHC injection mixed with solvent DMSO

Also known as: Calcitriol, Vitamin D

Experimental group: 1,25 DHC in DMSO

Placebo: plain DMSO solvent DRUG

Control: placebo: participants in this arm will receive plain DMSO solvent

Also known as: DMSO

Control Group: placebo

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with permanent dentition
• Angles class 1,class II dental malocclusion, indicated for bilateral maxillary first premolar extraction
• minimum 5 of extraction space

You may not qualify if:

• several craniofacial deformities such as cleft lip and palate
• history of bone disease such as osteoporosis or diabetes
• pregnant and lactating women

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 44000, Pakistan

RECRUITING

Related Publications (1)

• Arqub SA, Gandhi V, Iverson MG, Ahmed M, Kuo CL, Mu J, Dutra E, Uribe F. The effect of the local administration of biological substances on the rate of orthodontic tooth movement: a systematic review of human studies. Progress in Orthodontics. 2021 Feb 1;22(1):5.

  RESULT

MeSH Terms

Conditions

Malocclusion

Interventions

Calcitriol; Vitamin D; Dimethyl Sulfoxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids; Sulfoxides; Sulfur Compounds; Organic Chemicals

Study Officials

• Syeda Hareem Bukhari, BDS, Resident Orthodontics

  Foundation University Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Shoaib Rahim, FCPS

CONTACT

923215097582; clinicaltrials.fucd@fui.edu.pk

Dr Syeda Hareem Bukhari, BDS, Resident Orthodontics

CONTACT

923207351191; hareembukhari202@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: double blinded, split mouth parallel group randomized control trial with two arms. Patients will be randomly assigned to each group

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: March 18, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 15/05/2026 till forever
• Access Criteria: IPD document will be shared with the journal and will be available to all on request

Locations

PA (1)